(59 days)
To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
They consist of a rigid, mechanical, steel(HBG12-S)/aluminum(HBL13) frame and nylon upholstery back and seat. They have two 24" rear wheels and two 8" front casters for turning and maneuverability.
The provided text describes a 510(k) premarket notification for manual wheelchairs and does not contain information about an AI device or its performance criteria, studies, or associated details like sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot extract the requested information to fill in the table and answer the questions.
The document is a 510(k) summary for the "HUBANG HBL13/HBG12-S manual wheelchair" submitted by Shanghai Hubang Medical Appliances Co., Ltd. It states that the device is substantially equivalent to a predicate device (Solara, K012370) and meets applicable performance requirements specified in ANSI/RESNA WC Vol. 1 Sec. 1. Sec.5, Sec.7, Sec.8, Sec.15, Sec.16, and California Bureau of Home Furnishings 117. This refers to physical and mechanical testing standards for wheelchairs, not AI performance.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).